ApprovalTrail

Approval · Notice of Compliance 23045 · 2019

OLIMEL 3.3% E: Notice of Compliance 23045

Issued December 20, 2019

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number
23045
Date
December 20, 2019
Company
Baxter CorporationMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
To add safety related changes to the drug interactions,, overdosage and consumer information sections of the pm. additional dosage information for special populations (crrt and obese patients) based on established clinical guideliness

Products in this notice

BrandDINStatus today
OLIMEL 3.3% ENot yet assigned—
OLIMEL 4.4%Not yet assigned—
OLIMEL 4.4% ENot yet assigned—
OLIMEL 5.7%Not yet assigned—
OLIMEL 5.7% ENot yet assigned—
OLIMEL 7.6%Not yet assigned—
OLIMEL 7.6% ENot yet assigned—
PERIOLIMEL 2.5% ENot yet assigned—

Medicinal ingredients